None listed
Conditions
Brief summary
Based on the results from our PiPIN trial (REC 1774/12/08, ACTRN12606000525583) - where increasing the protein content of human milk fortifier resulted in a borderline significant increase in length gain (P=0.08) but a significant reduction in SGA for length in preterm infants – we hypothesise a higher level of protein is required to meet the growth needs of preterm infants. In this study we wish to increase the protein fortification to 1.8g protein/100ml breast milk compared with standard fortification 1g/100ml. A novel aspect of this study is that we will deliver an ‘entrée’ of fortifier directly through the naso-gastric tube rather than mix the fortifier in expressed breast milk as is current practice. Our novel approach allows direct breast feeds to be fortified. Currently when babies feed directly from the breast their feeds are not fortified contributing to the growth deficits seen in breast fed preterm infants. This study will therefore test the effect of increasing the protein content of human milk fortifier on growth and the feasibility of delivering a fortifier solution directly to the infant.
Interventions
Human milk fortifier is given as standard clinical practice to preterm infants, increasing the protein content by 1g/100ml breast milk. This intervention will add an additional 0.8g protein/100ml breast milk, thus intervention infants will receive 1.8g protein/100ml breast milk and 25 cal/30 ml.
The intervention will begin when the attending clinician prescribes the infant fortifier. Fortifier is given with all expressed breast milk feeds and this will be the case for this study. The study will
Human milk fortifier is given as standard clinical practice to preterm infants, increasing the protein content by 1g/100ml breast milk. This intervention will add an additional 0.8g protein/100ml breast milk, thus intervention infants will receive 1.8g protein/100ml breast milk and 25 cal/30 ml. The intervention will begin when the attending clinician prescribes the infant fortifier. Fortifier is given with all expressed breast milk feeds and this will be the case for this study. The study will cease at discharge or estimated delivery date, whichever occurs first.
Sponsors
Women's and Children's Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
28 Weeks to 32 Weeks
Healthy volunteers
No
Inclusion criteria
Infants <33 completed weeks gestation whose mothers intend to provide breast milk and have the written informed consent of their parents/guardians.
Exclusion criteria
Infants with major congenital or chromosomal abnormalities known to affect growth or where protein therapy is contraindicated e.g. major heart defects, cystic fibrosis, phenylketonuria, disorders of the urea cycle. Infants likely to transfer to remote locations where weekly blood tests are unable to be performed.
Outcome results
None listed